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Generated: May 25, 2017

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Details for New Drug Application (NDA): 065108

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NDA 065108 describes NEOMYCIN AND POLYMYXIN B SULFATE, which is a drug marketed by X Gen Pharms, Watson Labs, Bausch And Lomb, Perrigo Co Tennessee, Akorn, Alcon Pharms Ltd, Ipharm, Amring Pharms, and Sandoz Inc, and is included in twenty-one NDAs. It is available from two suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATE profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATE is bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for NDA: 065108

Formulation / Manufacturing:see details

Pharmacology for NDA: 065108

Suppliers and Packaging for NDA: 065108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
neomycin sulfate; polymyxin b sulfate
SOLUTION;IRRIGATION 065108 ANDA X-GEN Pharmaceuticals, Inc. 39822-1220 39822-1220-1 1 VIAL, GLASS in 1 CARTON (39822-1220-1) > 20 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrengthEQ 40MG BASE/ML;200,000 UNITS/ML
Approval Date:Jan 31, 2006TE:ATRLD:No

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